Lewiston

Researchers are studying the use of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment for people with treatment-resistant depression. The study aims to find out if active VNS therapy can reduce the severity of depression symptoms compared to no stimulation over a 12-month period. This is a randomized, controlled, and blinded trial involving subjects implanted with the VNS device. Participants are randomly assigned to one of two groups: one group will have the VNS device activated two weeks after implantation, while the other group will have the device implanted but not activated for the first 12 months. After 12 months, those in the control group may receive stimulation. After completing the 12-month randomized portion, all subjects can join an open-label, longer-term study lasting about 5 years to continue monitoring. During the study, participants will undergo assessments using several depression rating scales at regular intervals, including the Montgomery Åsberg Depression Rating Scale (MADRS), with evaluation of response, remission, and duration of effects. Additional measures include assessments of disability, health outcomes, clinical global impressions, and suicidality tracking. Safety and adverse events are also monitored from implantation through 12 months.

Researchers are evaluating ALTO-207 compared to a placebo in adults with treatment-resistant depression (TRD) to measure changes in depressive symptoms. This phase 2 trial aims to better understand the effects of ALTO-207 on depression severity in participants who have not responded well to previous antidepressant treatments. Participants will be randomly assigned to receive either ALTO-207 twice daily or a matching placebo. The study is double-blind and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 8 weeks, during which changes in depressive symptoms will be closely monitored. During the study, participants will undergo assessments including the Montgomery-Åsberg Depression Rating Scale (MADRS) to track changes in depression severity from the start through 8 weeks. Additional evaluations include response rates and clinical global impressions of severity over time. Safety and symptom monitoring will occur throughout, and participation may last up to 8 weeks based on treatment and follow-up visits.